DATA INTEGRITY IN QUALIFICATION SERVICES

AGILENT ENTERPRISE EDITION

Introduction
Sections This document provides the Agilent position on Data Integrity, in particular
Introduction when applied to electronic data generated in the course of Analytical Instrument
Qualification (AIQ) activities executed with the Automated Compliance Engine (ACE)
Agilent Automated software. Data Integrity refers to the completeness, trustworthiness and accuracy
Compliance Engine (ACE) of a given set of data, electronic or otherwise. Data Integrity is further qualified by
the intended use of the data and its impact on critical functions, decision making,
Intended Use and planning processes, and other implications to liability.
Regulatory Environment Two approaches to execute an automated AIQ using electronic data and reports
depend on whether the qualification software application is embedded in the native
Traceability and
Chromatography Data System (CDS) environment or is designed to be independent
Audit Trails from the CDS. When properly implemented, both are equally valid and provide
Data Processing and equivalent assurance of compliance. Of key importance is not the platform but the
features and controls that guarantee compliance with all requirements.
Reporting
Authenticated Access Agilent Automated Compliance Engine (ACE)
Agilent Enterprise Edition services are designed to guarantee full compliance with
Risk Assessment: the most stringent quality standards applicable to the AIQ. Enterprise Edition
Commercial off-the- uses ACE as the delivery tool, a software platform independent from the CDS that
shelf controls the instruments and monitors their daily operation. ACE provides the
technical and procedural controls required to:
Summary
1. Ensure data integrity by providing a secure and validated framework that
assesses the completeness, trustworthiness and reliability of records created
during the qualification with end-to-end traceability
2. Prevent and detect improper practices during the qualification service that may
compromise data integrity, such as testing into compliance or testing
towards outcome
3. Implement proper segregation of duties with access controls that limit use of the
instrument to only authorized qualified personnel

Page 1 of 4
Intended Use and Regulatory Environment
ACE is designed as a tool to deliver equipment qualification
services on laboratory instruments such as chromatography
systems. Risk assessment of a computer system, according
to the latest FDA and GAMP guidance documents, depends
on the definition and intended use of the electronic records
handled by the system.
In this regard the following facts are to be considered:
ACE delivers equipment qualification records and
calibration records that are classed as secondary data
and not directly related to drug production quality, patient
safety or confidentiality
ACE raw data (GMP) or original records (GLP) are delivered
as secure electronic Adobe Acrobat documents following
an automated and approved process within the software.
Paper copies of these documents can represent complete
and accurate reproductions of the electronic documents.
The qualification deliverables are completely self-
contained; they include all data, chromatographs,
reports, and other auxiliary documentation required to
support an audit. These include, but are not limited to,
certificates of analysis for the standards used, certificates
of calibration for the equipment, and training certificates
of the Agilent-authorized support representative.
Rules that affect this software and its intended use are
all the FDA and equivalent international predicate laws
(including national GMP and GLP) that relate to equipment
qualification, calibration and system validation. ACE is a
commercial-off-the-shelf software suite with adequate
controls, electronic records and electronic signatures for
its intended use.
Page 2 of 4
Traceability and Audit Trails
Data are generated by the same native chromatography data
system (CDS) used in the daily operation of the instrument,
which controls the system being qualified during the
complete qualification process. At no time is this connection
severed or altered in any way. The CDS audit trail maintains
a record of the complete interaction with the system under
qualification. The creation and access of data files are
captured in the CDS audit trail and are subject to the access
controls specified in the firms Standard Operating Procedure.
ACE typically runs on a USB spinning drive connected
to a computer with access to the system. ACE operates
independently and leaves no footprint on the computer. ACE
creates a true copy of the electronic data included within the
qualification report to maintain traceability to the original
data by means of data file name, date and time stamps, and
original acquisition folder in the CDS and processing folder
within ACE. This process is completely automated and not
subject to operator changes.
Other ACE use cases provide tight integration with the lab
practices and IT systems to ensure strong custody and access
control. Examples include a dedicated USB drive kept on the
customer premises or installed on the customer network to
use as a dedicated node for qualification deliveries.
Data Processing and Reporting
Data are processed using the calculation engine built into
ACE. All quality decisions about the pass/fail status of tests
performed during a qualification are automatically executed
within the ACE software. This provides a consistent and
harmonized approach to all qualification records for all
systems and techniques irrespective of their controlling CDS,
with the added benefit of an independent assessment of
system performancenot one conditioned by the
native CDS.
ACE automatically creates an electronic Equipment
Qualification Report (EQR) that includes a summary of test
conditions and pass/fail results. The EQR is delivered as a
secured .pdf file electronically signed by the Agilent service
representative. The report includes a graphical representation
of the electronically embedded chromatograms and shows
the integration results. A complete set of electronic data and
metadata used in all tests is delivered to the customer upon
completion. A counter is incremented each time a specific
test is processed and is included in the test summary as an
effective electronic deviation. If a test must be repeated, the
failed test results are available optionally as attachments to
the EQR upon customer request.
Example Information Fields Provided in an Equipment Qualification Report (EQR)
I. Session vital constants are documented in the front cover and footer on each page of the report, including system ID and
service creation date/time stamps.

II. A Data Audit Log per test, detailing the Host Name (PC), Original Data Path in the native CDS, and Analyzed Data Path
within ACE.

III. General information fields per data file acquired, including the Operator name, Acquisition Method used, data file name
and Acquisition date.

IV. Front cover of report showing customer V. Graphical printout of the chromatogram integrated by ACE, showing the
details, system ID and EQP name/ integration of the actual signal with the relevant integration results for
revision used. each data file acquired.

Page 3 of 4
Authenticated Access
ACE software access requires a secure log-in with password
rights assigned only to trained and certified Agilent Support
Representatives. Integrity of the password and username
combination is ensured by a unique username assigned and
managed by Agilent and a personal password chosen by the
operator, enforced by annual changes. Sharing of passwords
is prohibited. Unauthorized use is detectable at delivery of
reports generated by ACE. No tokens, cards or devices are
currently used in the ACE system. Access to ACE USB drives
is limited to authorized individuals.
Risk Assessment: Commercial off-the-shelf
ACE software is validated by the developer (Agilent
Technologies Inc.) as part of the Enterprise Edition
compliance services. ACE is designed to follow the stringent
quality requirements documented in the Agilent Lifecycle
process. A Declaration of Product Validation is issued with
each revision of the software. A detailed validation binder
is available upon customer request under confidentiality
agreement that describes the specific design requirements,
test cases and test results to which each ACE revision
is subjected prior to obtaining cross-functional approvals
for release. Each individual instance of ACE is qualified
by an automated IQ at installation and a semi-automated
OQ. Records of the qualification are included as auxiliary
documents of the Equipment Qualification Report (EQR).
Page 4 of 4
Summary
Agilent ACE software is designed to be independent of the
CDS that controls the system. It provides an independent
and validated assessment of laboratory equipment that
is harmonized across multiple techniques and vendors,
with reports that are easier to review and approve. Built-in
electronic controls ensure end-to-end traceability of the
qualification process. ACE integrates into the laboratory
infrastructure, and can adapt easily to procedural controls
documented in the customers SOP, supporting a wide variety
of use cases.
Equipment is qualified exactly as operated in the lab, at all
times under control of the installed CDS. Chromatography data
are generated by the native CDS and may be exported into
AIA format, with directory permissions subject to the firms
information technology (IT) policy and data retention SOP.
The ACE software typically runs from an attached USB drive;
it makes no changes and installs no files on the native CDS.
ACE has read-only access to the CDS and is controlled by an
automated data import process that is not subject to operator
changes. ACE may be accessed only by an authorized Agilent
engineer or customer using a secure log-in with password,
and may be further integrated into the customers lab
infrastructure, IT, and security systems as desired.
www.agilent.com/chem/enterprise
Information, descriptions and specifications in this
publication are subject to change without notice.
Agilent Technologies, Inc. 2013
Published in USA, November 27, 2013
5991-3652EN